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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K944541
Device Name HANDYPACK 911SC
Applicant
PACE TECH, INC.
510 GARDEN AVE. NORTH
CLEARWATER,  FL  33755
Applicant Contact ILHAN BILGUTAY
Correspondent
PACE TECH, INC.
510 GARDEN AVE. NORTH
CLEARWATER,  FL  33755
Correspondent Contact ILHAN BILGUTAY
Regulation Number868.1400
Classification Product Code
CCK  
Date Received09/15/1994
Decision Date 02/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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